The following data is part of a premarket notification filed by Phamatech with the FDA for Quickscreen At Home Drug Test, Model 9149/9150.
| Device ID | K982621 |
| 510k Number | K982621 |
| Device Name: | QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150 |
| Classification | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter |
| Applicant | PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Contact | Carl A Mongiovi |
| Correspondent | Carl A Mongiovi PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Product Code | MVO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-28 |
| Decision Date | 1998-10-16 |
| Summary: | summary |